Drugs@FDA: FDA-Approved Drugs

New Drug Application (NDA): 050547
Company: STERIMAX

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CLAFORAN	CEFOTAXIME SODIUM	EQ 500MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE;INJECTION	Discontinued	None	Yes	No
CLAFORAN	CEFOTAXIME SODIUM	EQ 1GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE;INJECTION	Discontinued	None	Yes	No
CLAFORAN	CEFOTAXIME SODIUM	EQ 2GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE;INJECTION	Discontinued	None	Yes	No
CLAFORAN	CEFOTAXIME SODIUM	EQ 10GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE;INJECTION	Discontinued	None	Yes	No

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/23/2015	SUPPL-71	Labeling-Package Insert	Label (PDF)	Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050547s071,050596s042lbl.pdf
02/21/2014	SUPPL-70	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050547s070,050596s040lbl.pdf
09/09/2011	SUPPL-68	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050547s068,050596s037lbl.pdf
02/21/2008	SUPPL-66	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050596s035,050547s066lbl.pdf